Oraverse Versus Laser

NCT ID: NCT05473858

Last Updated: 2022-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-10

Study Completion Date

2022-10-01

Brief Summary

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clinically assess the reversal of articaine 4% of two different concentration of vasoconcentration soft-tissue local anesthesia in pediatric dentistry using Diode Laser and Oraverse

Detailed Description

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Patients will be divided randomly into two groups (20 patients in each group) Group (1): Patients will be undergoing anesthesia revision by diode laser Group (2): Patients will be undergoing anesthesia revision by oraverse. Then each group will be subdivided into 2 subgroups (10 patients each) according to type of local anesthetic agent into:

subgroup 1: Articaine 4% with 1:100000 epinephrin \&Subgroup 2: Articaine 4% with 1:200000 epinephrin After 30 min of injection corresponding to approximate time of treatment, the patient in each group will be exposed to the reversal agent which may be diode laser or oraverse.

Conditions

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Reversal of Local Anesthesia in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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laser group

Patients will be undergoing anesthesia revision by diode laser

Group Type EXPERIMENTAL

diode laser

Intervention Type DEVICE

patient exposed to diode laser

oraverse group

Patients will be undergoing anesthesia revision by oraverse

Group Type EXPERIMENTAL

OraVerse Injectable Product

Intervention Type DRUG

injection of oraverse,

Interventions

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OraVerse Injectable Product

injection of oraverse,

Intervention Type DRUG

diode laser

patient exposed to diode laser

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients who need to be treated under anesthesia by injecting mandibular first molar infiltration.
2. Cooperative children aged 6 to 10 years old with the ability to understand and respond to the sensation of soft tissue -
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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sara nabil

OTHER

Sponsor Role lead

Responsible Party

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sara nabil

Lecturer of pediatric dentistry

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Dr.sara nabil

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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sara nabil, DR

Role: CONTACT

00201006420998

Facility Contacts

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sara nabil, doctor

Role: primary

Other Identifiers

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AlAzhar

Identifier Type: -

Identifier Source: org_study_id

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